ISO
13485
Medical-grade QMS CERTIFIED · 2025
ISO 13485:2016 CERTIFIED · EST. 1980

45 years of precision plastic injection,
from mold design to medical-grade production.

Shih Gong Enterprise Co., Ltd. specializes in precision plastic injection mold design and manufacturing. We provide one-stop OEM / ODM co-development, injection molding, and post-processing across headphones, optics, consumer electronics, medical devices, and sanitary ware — all under ISO 13485:2016 medical-device quality management.

45+
YEARS IN MOLDING
93
PRODUCTS DELIVERED
ISO
13485:2016 CERTIFIED
OEM
ODM
CO-DEVELOPMENT
CORE CAPABILITIES

From CAD file to finished part — one supplier.

We cover the full plastic-product pipeline: design optimization, tooling, injection molding, and surface finishing. Brand owners stay focused on the product; we handle the making.

ISO
13485
Certified to ISO 13485:2016 — Medical Device QMS · January 2025 QUALIFIED FOR MEDICAL-GRADE PLASTIC COMPONENT MANUFACTURING
View Certifications
Shih Gong factory Watch company video 47 sec
ABOUT SHIH GONG

Quality is designed in — not inspected in.

Shih Gong holds "quality is designed in" as our core value, with 45 years focused on precision injection mold design and manufacturing. From the earliest mold-design phase, we apply a reverse-engineering mindset built on decades of production experience — pursuing the highest possible yield as our first principle. Because precision tooling is what makes high-quality mass production possible.

From mold development to high-efficiency injection machines to post-processing, Shih Gong vertically integrates its supplier network — committed to Designed, Tooled, and Made in Taiwan. Our work spans electronic toys, mobile communications, medical devices, headphones & audio, 3C accessories, and sanitary ware components — fulfilling orders from around the world with the speed and customization each customer's specs, quality bar, and timeline demand.

  • 2D / 3D mold design
  • Precision injection molding
  • Metal parts & jig/fixture
  • Electroplating / Anodizing
  • Spray coating / Printing
  • Laser engraving / Heat transfer
PRODUCT CATEGORIES

Six product domains, one standard.

From consumer-grade earphone shells to medical-grade diagnostic components, Shih Gong applies the same precision-molding and finishing discipline to every project — only regulatory rigor and scale differ.

FREQUENTLY ASKED

The four questions buyers ask first

MOQ, lead time, what ISO 13485 means, available materials — the things B2B buyers want answered before a conversation. Full list at FAQ page.

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CERTIFICATIONS

Certifications

Meeting international quality standards isn't optional — it's how we earn the right to serve medical-device makers.

Shih Gong ISO 13485:2016 medical device quality management certificate
// 2025

ISO 13485:2016

Medical Device Quality Management System, certified January 2025. Validates our capability to manufacture regulated plastic components for medical-device customers.

Shih Gong 45 years of plastic injection production experience
// 1980–

45 Years of Production

Four manufacturing cycles — home appliances, 3C, smartphones, wearables, and now medical devices. We've accumulated not just hours, but the kind of process intuition that only comes from past mistakes.

Shih Gong OEM ODM co-development with engineers reviewing mold design and plastic samples
// OEM/ODM

Co-Development

OEM, ODM, custom projects — we don't gatekeep. But at the feasibility stage we tell you honestly which parts of the design are buildable and which ones need rework.

LET'S BUILD TOGETHER

Got a sketch, a 3D file, or just a concept?

Whether it's hand-drawn or a finalized STEP file, our engineering team can take it through feasibility, mold-flow analysis, and into production.